The European Commission shows regulatory flexibility due to Covid-19

With its Recommendation (EU) 2020/403, the European Commission today presented measures to significantly speed up and simplify procedures for the distribution of personal protective equipment (PPE) and medical devices: Manufacturers of PPE and medical devices can now, as an exceptional case, already place their products on the market without the otherwise necessary CE marking.

The current coronavirus situation has led to a growing demand for face masks, protective suits, safety glasses, surgical masks and examination gloves. These products fall within either the PPE Regulation (EU) 2016/425 or the Medical Devices Directive 93/42/EEC. Both works of harmonisation legislation lay down very demanding requirements for technical design, manufacture and sale, in particular high health and safety requirements.

In order to determine whether products comply with these requirements within the company, certain types of products will normally have to undergo a conformity assessment procedure. External testing laboratories (notified bodies) must be involved in this process, which confirm the conformity of the products with the corresponding harmonisation rule, often by means of harmonised European technical standards. Only after the completion of this procedure can the product be marked with the CE marking, which is a prerequisite for lawfully placing the product on the market.

In view of the supply bottlenecks for these products, the increase in demand and the partial disruption of supply chains, the industry is already responding by increasing the production of these products. The Commission wants this increased supply to be put on the market without undue delay.

Therefore, in its Recommendation (EU) 2020/403, the European Commission has now set out a series of measures to ensure faster delivery of these products onto the market:

Firstly, PPE and medical devices can already be placed on the market without the CE marking. Market surveillance authorities will assess these products themselves – no longer only notified bodies – and, if they are found to be in conformity with the essential health and safety requirements of the relevant harmonisation legislation, market surveillance authorities will take measures to allow the PPE and medical devices concerned to be placed on the EU market within a limited period or during the notified body’s ongoing conformity assessment process. This is possible even if the PPE and medical devices are not fully in line with the corresponding harmonised technical standards!

It should be noted, however, that these products without CE marking are only available to medical professionals and only for the duration of the current health threat and that they cannot be placed in the normal distribution channels and thus made available to private customers.